In modern society, due to the increasing competition and the accelerated pace of life, more and more people suffer from anxiety and sleep disorder. The function of current sedative hypnotics and anti-anxiety drugs (such as the benzodiazepine class) is characterized by making insomniacs fall asleep quickly. Although the time of light sleep may be prolonged, two important kinds of sleep, slow-wave sleep (SWS) and rapid eye movement sleep (REMS), are damaged in varying degrees. Accordingly, the sleeping quality has not been really improved, and the phenomena of dizziness, fatigue, drowsiness, inattention and the like occur inevitably. Repeated administration may result in psychological and physical dependence. A new generation of anti-anxiety, sedative hypnotics (such as buspirone) has made much progress in improving the sleeping quality, and without obvious addiction. However, after administration, side effects of dizziness, headache, and gastrointestinal disorders may occur. Therefore, it is necessary to continue to seek and develop new medicaments for the treatment of anxiety and sleep disorder.
Albiflorin is a natural active substance categorized as monoterpene, with a molecular formula of C23H28O11 and a molecular weight of 480.46, and the molecular structure thereof is shown in Formula I. It is originated from the root of Paeonia lactiflora Pall, Paeonia veitchii Lynch or P. suffrsticosa Andrz of Ranunculaceae plants.

Albiflorin has a cyclic structure of lactone, but without a hemiacetal structure. It is converted under anaerobic conditions into two products, paeonilactone A and paeonilactone B, respectively. The structures of paeonilactone A and B are shown as Formula (II) and Formula (III), respectively:

Modern pharmacological studies indicate that Albiflorin has analgesic, anticonvulsant effects, immune system-related effects, smooth muscle-related effects, anti-inflammatory effect, effects against pathogenic microorganisms, and liver protection effect. Clinically speaking, it is mainly used for anti-epilepsia, analgesia, drug abuse rehabilitation, nausea-stopping, the treatment of rheumatoid arthritis, the treatment of bacillary dysentery and enteritis, the treatment of viral hepatitis, the treatment of age-related diseases, the resistance to barium sulfate flocculation and mucus dissolution.
As stated in the prior art (Anping, ZHANG et al., Effects of total glucosides of paeony on sleep-waking rhythm in rats, Chinese Pharmacological Bulletin, 1993, 9 (6): 454), the total glucosides of paeony are active components extracted from Paeonia lactiflora Pall, including paeoniflorin, hydroxyl paeoniflorin, paeonin, albiflorin, benzoyl paeoniflorin and the like, wherein the content of paeoniflorin is more than 90% with respect to the total glycosides. Therefore, the pharmacological effects of the total glucosides of paeony are substantially represented as those of paeoniflorin, and the total glucosides of paeony have effects on the sleep-waking rhythm in rats. In other words, it is only recorded in the prior art that the total glucosides of paeony have effects on the sleep-waking rhythm in rats, but there in no teaching of the efficacy of albiflorin as a monomer compound for the treatment of anxiety and sleeping disorder.
By means of advanced separation and purification technology, the inventor extracts albiflorin, the active component for the treatment of anxiety and sleep disorder, from the root of Paeonia lactiflora Pall, with a purity of 50-99%, and the inventor makes pharmacodynamical and pharmacological studies of albiflorin and the corresponding pharmaceutical preparations thereof on the amelioration, treatment of anxiety and sleep disorder (especially the treatment of sleep disorder associated with depression). The results showed that the albiflorin monomer are of clear pharmacological effects for treating anxiety and sleep disorder, significant therapeutic effect, low toxicity and side effects, and high safety. Albiflorin may also make it possible to provide a highly effective and low-toxic medicament for patients suffering from anxiety and sleep disorder. In addition, the comparison between paeoniflorin and albiflorin in the improvement of sleep disorder is also performed. The experimental results showed that albiflorin is notably better than paeoniflorin (which is the main effective component of the total glucosides of peony for treating anxiety and improving sleep disorder) in the improvement of sleep disorder. The traditional view is corrected due to these results.
Health-care food, also called as dietary supplement, is an oral product or preparation containing nutrients, which are uptaken for the purpose of increasing the nutrient in addition to daily meals. It is not a drug, but a kind of food. However, it also differs from those on the table during three meals a day. “Health-care food” falls into the scope of food, but differs from that in the traditional sense. Its function is intended to supply nutrients in addition to daily meals, regulate body functions, and enhance physical fitness.